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CHANTIX (CHAMPIX): MEDICATION GUIDE

Champix (Chantix) (Varenicline Tartrate) Tablets

Read the Medication Guide that comes with Chantix (Champix) before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your condition or treatment.

What is the most important information I should know about Chantix (Champix)?

Some people have had changes in hostility, behavior, agitation, depressed mood, and suicidal thoughts or actions while using this medication to help them quit smoking. Some people had these symptoms when they began taking Chantix (Varenicline), and others developed them after several weeks of treatment, or after stopping this drug.

If you, your family, or caregiver notice agitation, hostility, depression or changes in behavior or thinking that are not typical for you, or you develop any of the following symptoms, stop taking Chantix (Varenicline Tartrate) and call your doctor right away:

new or worse depression, anxiety, or panic attacks

thoughts about suicide or dying, or attempts to commit suicide

feeling very agitated or restless

acting on dangerous impulses

acting aggressive, being angry, or violent

an extreme increase in activity and talking (mania)

seeing or hearing things that are not there (hallucinations)

abnormal thoughts or sensations

feeling people are against you (paranoia)

feeling confused

other unusual changes in behavior or mood

When you try to quit smoking, with or without Varenicline (Chantix), you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, irritability, trouble sleeping, frustration, anger, difficulty concentrating, feeling anxious, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.

Before taking Varenicline Tartrate (Chantix), tell your doctor if you have ever had depression or other mental health problems. You should also tell your doctor about any symptoms you had during other times you tried to quit smoking, with or without this medicine.

Some people can have allergic reactions to Chantix (Varenicline). Some of these allergic reactions can be life-threatening and include: swelling of the face, mouth (tongue, lips), and throat that can cause trouble breathing. If you have these symptoms, stop taking this medication and get medical attention right away.

Some people can have serious skin reactions while taking Chantix (Champix). These can include rash, swelling, redness, and peeling of the skin. Some of these reactions can become life-threatening. If you have a rash with peeling skin or blisters in your mouth, stop taking this medicine and see your doctor right away.

What is Chantix (Champix)?

Chantix (Champix) is a prescription medicine to help adults stop smoking. Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking.

This medicine is not recommended for people under 18 years of age.

Chantix (Varenicline) has not been studied with other treatments for stopping smoking.

Who should not take Chantix (Champix)?

Do not take Champix (Chantix) if you have had a serious allergic or skin reaction to this medication, which may include:

swelling of the mouth, face, and throat that can cause trouble breathing

swelling, rash, redness, and peeling of the skin

What should I tell my doctor before taking Chantix (Champix)?

Before you take this drug, tell your doctor if you:

have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of Varenicline (Chantix) for you

have ever had depression or other mental health problems

have heart or blood vessel problems

have any other medical conditions

have any allergies

are pregnant or plan to become pregnant. Ask your doctor for help to stop smoking before you get pregnant because smoking during pregnancy puts you and your baby at risk for problems during pregnancy. Varenicline Tartrate (Chantix) has not been studied in pregnant women. It is not known if this medicine will harm your unborn baby.

are breastfeeding. Chantix (Varenicline) has not been studied in breastfeeding women. It is not known if this medication passes into breast milk. You and your doctor should talk about the best way to feed your baby if you take Champix (Chantix).

Tell your doctor about all your other medicines, including prescription and nonprescription medicines, vitamins and herbal supplements. Especially, tell your doctor if you take:

asthma medicines

insulin

blood thinners

When you stop smoking, there may be a change in how these and other medicines work for you.

You should not use Chantix (Varenicline Tartrate) while using other medicines to quit smoking. Tell your doctor if you use other treatments to quit smoking. Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist when you get a new medicine.

How should I take Chantix (Champix)?

There are 2 ways that you can use Champix (Chantix) to help you quit smoking. Talk to your doctor about the following 2 ways to use this drug:

1. Choose a quit date when you will stop smoking. Start taking Chantix (Varenicline Tartrate) 1 week (7 days) before your quit date. This lets this medicine build up in your body. You can keep smoking during this time. Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take Varenicline (Chantix) for a few weeks for this medication to work best.

OR

2. You can also start taking Varenicline (Chantix) before you choose a quit date. Pick a date to quit smoking that is between days 8 and 35 of treatment. Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take Varenicline Tartrate (Chantix) for a few weeks for this drug to work best.

Take Chantix exactly as prescribed by your doctor.

1. Take Chantix (Varenicline) after eating and with a full glass (8 ounces) of water.

2. Most people will take Chantix (Varenicline Tartrate) for up to 12 weeks. If you have completely quit smoking by 12 weeks, your doctor may prescribe this medicine for another 12 weeks to help you stay cigarette-free.

Chantix (Champix) comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet. See the chart below for dosing instructions.

Day 1 to Day 3: White tablet (0.5 mg): Take 1 tablet each day

Day 4 to Day 7: White tablet (0.5 mg): Take 1 in the morning and 1 in the evening

Day 8 to end of treatment: Blue tablet (1 mg): Take 1 in the morning and 1 in the evening

This dosing schedule may not be right for everyone. Talk to your doctor if you are having side effects such as nausea, strange dreams, or sleep problems. Your doctor may want to reduce your dose.

If you miss a dose of Chantix (Varenicline Tartrate), take it as soon as you remember. If it is close to the time for your next dose, wait. Just take your next dose at your regular dose.

What should I avoid while taking Chantix (Champix)?

Use caution driving or operating machinery until you know how this medicine may affect you. Some people who use Champix (Chantix) may feel sleepy, dizzy, or have trouble concentrating, that can make it hard to drive or perform other activities safely.

What are the possible side effects of Chantix (Varenicline)?

Serious side effects of Chantix (Champix) may include:

New or worse mental health problems, which have been reported in some patients.

New or worse heart or blood vessel (cardiovascular) problems in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with Chantix (Varenicline Tartrate).

Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:

chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back

Tell your doctor about side effects that bother you or that do not go away.

These are not all the side effects of Varenicline Tartrate (Chantix). Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects.

How should I store Chantix (Champix)?

Store Champix (Chantix) at room temperature, 59 to 86°F (15 to 30°C).

Safely dispose of Chantix (Varenicline) that is out of date or no longer needed.

Keep this medication and all medicines out of the reach of children.

General information about Chantix (Varenicline Tartrate)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Varenicline (Chantix) for a condition for which it was not prescribed. Do not give your Chantix to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about this drug. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Chantix (Varenicline) that is written for healthcare professionals. For more about Chantix (Champix) and tips on how to quit smoking, go to this medicine official website.